UC Berkeley announced on Thursday a rollback in its controversial plan for voluntary genetics testing of incoming students, part of an orientation program called "Bring Your Genes to Cal." In response to a state Public Health Department ruling on how DNA samples should be handled, UC Berkeley scientists reluctantly abandoned the idea to have freshmen and transfer students individually and confidentially learn about three of their own genetic traits. Instead, only collective results for all the 1,000 or so participants will be available and discussed at the orientation seminars....Mark Schlissel, UC Berkeley's dean of biological sciences and an architect of the DNA program, said he disagreed with the state Department of Public Health's ruling that the genetic testing required advance approval from physicians and should be done only by specially-licensed clinical labs, not by university technicians. The campus could not find labs willing to do the work and probably could not afford it anyway, Schlissel said. He also contended that the project deserved an exemption from those rules because it was an educational exercise....Berkeley officials contend that the test results would not be medically significant. But the program was controversial with privacy advocates and ethicists complaining that it presented an unprecedented and disturbing use of genetic data by a university....In a statement issued Thursday, Kevin Reilly, an official at the state Public Health Department, said only licensed laboratories are allowed to perform medical tests on human specimens if the results are to be released to an individual. That rule is "designed to protect the public by ensuring that testing provides accurate and reliable results."
So it appears the UC Berkeley dean of biological sciences who hatched this idea has been stymied by the California state public health department, one of the toughest in the country. He and his other team members appear to have been blissfully unaware of the CLIA regulations whereby only licensed labs can release test results to individuals. Putting this all together, the project was probably only feasible from a cost perspective if the specimens were analyzed in a local research lab and not a CLIA-certified lab. In fact, the costs may have been covered by a research grant. When individual reporting was ruled out by the state authorities, the back-up plan was to reveal only collective results to the students.
So what was probably the real reason for this project? As noted above, I suspect that one or more researchers wanted access to a large pool of normal student samples as part of their research agenda. This is still possible with the revised plan but the number of specimens may be reduced absent the appeal of individual reports to the students. Forget all of the hot air about the educational benefits of the program for the incoming freshmen. This was mainly window dressing, in my opinion. In fact, Dean Schlissel admitted as much in the second news link above by saying the following:
"We're very much afraid that if (the ruling) is interpreted as applicable for other teaching programs ..., it will have a real stultifying effect on our ability to conduct research," said Dr. Mark Schlissel....
By the way, this same CLIA lab issue poses one of the major obstacle to the release of genetic test data to research subjects recruited for clinical trials. Most of this lab testing is performed in research labs similar to the one involved in the Berkeley project.